Pfizer & Genmab’s Tivdak Bags US FDA Nod to Treat Cervical Cancer

Pfizer Inc, a pharmaceutical industry firm and Genmab A/S reported that the US Food and Drug Administration (FDA) endorses the supplemental Biologics License Application (sBLA) giving full endorsement for Tivdak (tisotumab vedotin-tftv) for the therapy of patients with intermittent or metastatic cervical cancer with illness movement on or after chemotherapy.

"Recurrent or metastatic cervical cancer is a particularly devastating and mostly incurable disease, and patients are in need of survival-extending treatment options,” said Chris Boshoff, M.D., Ph.D., chief oncology officer, executive vice president at Pfizer. “Today’s full approval by the FDA reinforces the important role of Tivdak for these patients, as the first antibody-drug conjugate with statistically significant prolonged overall survival data.”

The global, randomized, Phase 3 innovaTV 301 clinical trial (NCT04697628) met its primary endpoint, demonstrating that adult patients with previously treated recurrent or metastatic cervical cancer treated with Tivdak outperformed chemotherapy in terms of overall survival (OS). Secondary endpoints of progression-free survival (PFS) and confirmed objective response rate (ORR) were likewise met. The innovaTV 301 study's findings were presented at the European Society of Medical Oncology (ESMO) Congress in October 2023 during the Presidential session.

“The full FDA approval of Tivdak represents a significant achievement for women with recurrent and metastatic cervical cancer, reinforcing Tivdak as a treatment option that has proven to extend survival in patients whose disease has advanced after initial treatments,” said Jan van de Winkel, Ph.D., chief executive officer of Genmab. “This milestone underscores the importance of our ongoing clinical development program to assess the full potential of tisotumab vedotin as a treatment option in other indications.”